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Nice Pak Senior Manager, Site Compliance in Orangeburg, New York

Description

Driven by a commitment to research, quality and service, PDI provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing 3 areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team!

POSITION PURPOSE

The Senior Manager, Site Compliance is responsible for the overall site regulatory and compliance activities and also for the implementation, management and monitoring the performance of the quality management system. This position is accountable for implementing the Corrective Action and Preventive Action (CAPA) Program and is accountable for remediation via CAPA, driving change and continuous improvement of the CAPA process including process and product related CAPA, coordinating CAPA actions with site Quality Management Representatives, and provides management with actionable data for Management Reviews. This position will serve as a QMS and remediation resource to site quality teams.

The incumbent will drive CAPA training and capability of CAPA owners. This position will routinely monitor the functioning of the customer service process to ensure it is capturing all pertinent information to ensure on time responses are provided as well as appropriate follow up with the sites is maintain. This position will also be a member of Core Development Teams as assigned by the Dir. of Quality and Compliance. The senior Manager, site Compliance lead is responsible for all regulatory and external agencies audits and is responsible for all site inspection management and site inspection readiness process. Additionally, the Sr manger is responsible for the management process of response preparation and routine and frequent updates.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

  • Provide strategic leadership, development and implementation of the assigned cGMP QA Systems for drug/device products. Responsible to coordinate Management Review meetings and metrics.

  • Contribute and maintain an effective Quality Management System (QMS) that complies with all regulatory requirements and applicable standards including FDA, EPA, ISO and Health Canada.

  • Oversee and manage all aspects of the assigned quality functions for Change Control.

  • Establish an ownership matrix and resolve escalated CAPA ownership issues causing delays in CAPA closure, including resource needs and facilitates procurement of resources, resolution of resource conflicts, and business justifications and/or trade-offs related to resource utilization.

  • Ensure robust investigations are conducted for CAPA with established root cause analysis, action plans and documented effectiveness criteria to assure full and effective closure without repeat CAPA.

  • Contribute quality and compliance expertise and guidance to CAPA owners responsible for addressing specific quality issues.

  • Develop and implement Quality Risk Management (QRM) process to support assessment of complex systems, critical deviations and corrective and preventive actions (CAPA).

  • Create a culture of sustainable quality through quality and compliance programs such as risk assessments, change management, data integrity, right first time, quality councils and critical quality metrics.

  • Contribute to the periodic Product Quality Review and present on their area of focus during the Management Review meetings.

  • Identify, assess and communicate QA strategies, metrics (KPIs), gaps and compliance risks for their assigned responsibilities to senior management.

  • Tracking, trending all KPIs (QA metrics) and design action plans to address trends.

  • Monitor the effectiveness of the QMS by establishing appropriate quality objectives, metrics, and compliance goals.

  • Partner with Product Development, Regulatory Affairs, Clinical Research, external vendors and partners to support corporate objectives and ensure compliance with all quality, regulatory and quality compliance requirements.

  • Lead and contribute to Regulatory /Corporate/site inspection readiness and commercial readiness preparations.

  • Support and/or host regulatory audits as requested; Federal, Notified Body for CE Mark, Local State including partner audits.

  • For their area of responsibility provide accurate budget forecasts.

  • As a key member of a Core Development Team, provide input to the team as required. Attendance and full engagement at all developmental meetings is expected.

  • Asist internal customer with technical support and status inquiries

  • Provide copies of controlled documentation for internal and external distribution

  • Develop, issue, and review product complaint and trending report with Business category leads, customer technical support, external customers and manufacturing sites.

PERFORMANCE MEASUREMENTS

  • As a key member of the Core Development Team the individual must enable rapid product development and product commercialization. The individual will be measured for both their own contribution to the team and the overall effectiveness of the entire team.

  • Participate in the periodic Product Quality Review meeting and all assigned Core Development Team activities.

  • Develop and implement Quality Risk Management (QRM) process to support assessment of complex systems, critical deviations and corrective and preventive actions (CAPA).

  • Establish and execute coaching programs for quality and other functions to educate on sustainable quality.

QUALIFICATIONS

Education/Certification:

  • Bachelor’s degree in a scientific discipline is required. An advanced degree is preferred

Required knowledge:

  • Working knowledge of ICH risk management tools, Failure Mode Effects Analysis (FMEA), and/or lean/Six sigma concepts.

Experience Required:

  • 5 – 10 years medical device and drug quality and regulatory experience in life sciences technology driven company.

  • Seasoned professional in managing cGMP Quality Systems (QA and QC) for drug/device products with a thorough knowledge of cGMP regulations (21CFR211, 21CFR820, EMA), ISO 13485, 9001, 22716, CE Marking and ICH guidance.

  • Experience in oversight of implementing cGMP computer systems with compliance to Part 11 and EU Annex 11 requirements i.e. Master Control.

  • Experience with USFDA/EU/CA inspections

Skills and abilities:

  • Exceptionally strong project management.

  • Ability to work independently on QA projects and initiatives with minimum supervision.

  • Pro-active in identifying opportunities along with strong problem solving and negotiation skills.

  • Ability to work "hands on" in an entrepreneurial, fast paced environment.

  • Leads by example and highly collaborative with the proven ability to work in a cross-functional team.

  • Self-starter and team player with strong leadership, administrative, interpersonal, and team-building skills.

  • Strong verbal, written communication skills and computer skills are required

  • Must be goal-oriented, quality-conscientious, and customer-focused.

Working conditions: No hazardous or significantly unpleasant conditions.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

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